Radium-223 treatment for prostate cancer with bone metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of Radium-223, a radionuclide therapy, in patients with metastatic castration-resistant prostate cancer (mCRPC) who have bone-only disease. Participants will receive standard treatment with Radium-223 while also undergoing 68Ga-PSMA-PET/CT scans to assess the presence of extraskeletal lesions. The study aims to evaluate the predictive value of these imaging results and the potential of circulating tumor DNA (ctDNA) as a biomarker for treatment response. Patients will be monitored throughout the treatment with questionnaires and imaging to determine the effectiveness of the therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate.
* Progressive disease after previous treatment defined as a rise in serum (Prostate Specific Antigen) PSA (PCWG3 criteria(22), see appendix 1) and/or progression on conventional imaging (PCWG3).
* A positive bone scan (osteoblastic bone metastases), with at least two metastases.
* Hemoglobin concentration \>10 g/dl (6.2 mmol/l) and thrombocytes \>100 109/I at baseline.
* Each patient will need to (continue to) receive adequate bone protective agents (e.g. bisphosphonates) and androgen deprivation therapy (ADT) according to current clinical guidelines.

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance score \>2
* Life expectancy \< 6 months.
* Detected extra-skeletal metastases or lymph node metastases (\>3 cm short axis) as identified by conventional imaging (ceCT thorax/abdomen)

Where it's running

• Nki-Avl
  Amsterdam, North Holland, Netherlands Recruiting
• Meander Medisch Centrum
  Amersfoort, Utrecht, Netherlands Recruiting
• Sint Antonius ziekenhuis
  Nieuwegein, Utrecht, Netherlands Recruiting
• Umc
  Utrecht, Netherlands Recruiting
• Diakonessenhuis
  Utrecht, Netherlands Not yet recruiting

Study contacts

• Principal investigator: J.C. van der Mijn — The Netherlands Cancer Institute
• Study coordinator: J.C. van der Mijn, Dr.
• Email: k.vd.mijn@nki.nl
• Phone: +31205129111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.